TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS

Nail, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Meta-nail Retrograde Femoral And Tibial Nails.

Pre-market Notification Details

• Device ID: K061019
• 510k Number: K061019
• Device Name: TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
• Classification: Nail, Fixation, Bone
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: David Henley
• Correspondent: David Henley; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JDS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-13
• Decision Date: 2006-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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